Effect of Active Drain Line Clearance on Catheter-Associated Bacteriuria

Not Applicable

Withdrawn

• Conditions: Burns; Critical Illness; Surgery; Urinary Tract Infections; Bacteriuria
• Interventions: Device: Standard of Care; Device: DLCS Group; Device: DLC Group

• Registration Number: NCT03816384
• Lead Sponsor: Potrero Medical

Brief Summary

Catheter-associated urinary tract infections (CAUTI) are the most common nosocomial infections in critically ill patients and are responsible for high morbidity rates, increased hospital stays and associated costs.

The purpose of this study is to evaluate whether active drain line clearance by the Accuryn Monitoring System reduces the incidence of CAUTI in hospitalized patients requiring catheters.

Detailed Description

Urinary tract infection (UTI) is the most common healthcare associated infection (HAI) acquired in hospitals and is estimated to account for approximately 13% of hospital infections in the United States, of which 75% are associated with indwelling urinary catheters. It is estimated that between 12-16% adult inpatients will receive an indwelling urinary catheter during their hospital stay. The rate of catheter-associated UTI (CAUTI) are highest in burn ICUs, followed by inpatient medical wards and neurosurgical ICUs.

The purpose of this study is to evaluate whether active drain line clearance by the Accuryn Monitoring System reduces the incidence of bacteriuria and/or CAUTI in patients requiring catheters for more than 72 hours. This study will also evaluate the efficacy in reducing bacteriuria of the Accuryn silver fabricated silicone catheters.

Study Timeline

• Study First Submitted: 2019-01-22
• Study First Submitted QC: 2019-01-22
• Study First Posted: 2019-01-25
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-27
• Last Update Posted: 2020-01-29
• Study Start: 2020-01-31
• Primary Completion: 2020-01-31
• Study Completion: 2020-01-31

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Adult (age ≥ 18)
2. Patient or Legally Authorized Representative (LAR) possess the capacity to provide informed consent
3. Indication for a urinary bladder catheter (or one currently in place)
4. Expected urinary catheter requirement ≥ 72 hours
5. No current urinary tract infection
6. No current indication for prophylactic antibiotics. If a surgical patient, receive perioperative antibiotics for no greater than 24 hours

Exclusion Criteria

1. Inability to receive a urinary bladder catheter
2. Chronic suprapubic catheter in place
3. Expected survival < 72 hours
4. Receipt of systemic antibiotics within 48 hours of enrollment, other than prophylactic antibiotics given at the time of surgery
5. Surgery of the genitourinary tract in the past 6 months prior to admission
6. Deemed unfit for the protocol by the investigator for any reason

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard of Care	Standard of Care	Patients will receive Standard of Care, commercially available catheter utilized by hospital system.
Drain Line Clearance and Silver (DLCS) Group	DLCS Group	Patients will receive FDA-approved Accuryn Monitoring System with active drain line clearance and silver-doped silicone catheter.
Drain Line Clearance (DLC) Group	DLC Group	Patients will receive FDA-approved Accuryn Monitoring System with active drain line clearance and plain silicone catheter.

Primary Outcome Measures

Name	Time	Method
Difference in percentage of catheter-associated bacteriuria	30 days	To study the difference in rate of catheter-associated bacteriuria between SOC catheters and Accuryn silicone or Accuryn silver-doped catheters with active drain line clearance.

Secondary Outcome Measures

Name	Time	Method
Urine Culture Comparisons	30 days	To study the correlation between patient urine cultures and cultures taken from the Foley (Foley tip, urine sampled from collection bag).
Percentage of asymptomatic (ASB) and symptomatic (CAUTI) bacteriuria	30 days	To study the incidence and progression of asymptomatic bacteriuria and CAUTI in patients with prolonged foley catheters for greater than 72 hours.
Time to Bacteriuria (ASB and CAUTI)	30 days	To study the progression of asymptomatic bacteriuria and CAUTI in patients with prolonged foley catheters for greater than 72 hours.